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Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

Sponsor
Novavax (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05463068
Collaborator
(none)
911
Enrollment
31
Locations
3
Arms
1.3
Anticipated Duration (Months)
29.4
Patients Per Site
22.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the vaccination.

Study Design

Study Type:
Interventional
Actual Enrollment :
911 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Actual Study Start Date :
Jul 11, 2022
Anticipated Primary Completion Date :
Aug 19, 2022
Anticipated Study Completion Date :
Aug 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lot 1

1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.

Drug: NVX-Cov2373
Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
Other Names:
  • SARS-CoV-2 rS/Matrix-M Adjuvant

    		•
    Experimental: Lot 2

    1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.

    Drug: NVX-Cov2373
    Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
    Other Names:
  • SARS-CoV-2 rS/Matrix-M Adjuvant

    		•
    Experimental: Lot 3

    1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.

    Drug: NVX-Cov2373
    Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
    Other Names:
  • SARS-CoV-2 rS/Matrix-M Adjuvant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMEUs [Day 29]

      IgG geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.

    Secondary Outcome Measures

    1. Serum IgG antibody levels expressed as seroconversion rate (SCR) [Day 29]

      Proportion of participants in each treatment arm who achieve seroconversion (≥ 4-fold increase from baseline) in IgG concentrations to the SARS-CoV-2 spike protein at Day 29.

    2. MN50 geometric mean titers (GMTs) to the SARS-CoV-2 expressed as GMTs [Day 29]

      MN50 geometric mean titers to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.

    3. MN50 GMTs to the SARS-CoV-2 expressed as SCR [Day 29]

      Proportion of participants in each treatment arm who achieve seroconversion (≥ 4-fold increase from baseline) in MN50 titers to the SARS-CoV-2 spike protein at Day 29.

    4. Human Angiotensin-Converting Enzyme 2 (hACE2) inhibition assay titers GMT to the SARS-CoV-2 expressed as GMT [Day 29]

      hACE2 inhibition assay titers (geometric mean titer [GMTs]) at Day 29 in each treatment arm.

    5. hACE2 inhibition assay titers to the SARS-CoV-2 expressed as SCR [Day 29]

      Proportion of participants in each treatment arm who achieve seroconversion (≥ 4-fold increase from baseline) in hACE2 titers concentrations to the SARS-CoV-2 spike protein at Day 29.

    6. Incidence and severity of MAAEs [Day 0 to Day 29]

      Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose).

    7. Incidence and severity of AESIs [Day 0 to Day 29]

      Incidence, duration, severity, and relationship of AESIs (including myocarditis and/or pericarditis) through Day 29 (ie, 28 days after vaccine dose).

    8. Incidence and relationship of SAEs [Day 0 to Day 29]

      Incidence and relationship of SAEs throughout the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    To be included in this study, each individual must satisfy all of the following criteria:

    1. Adults 18 to 49 years of age, inclusive, at screening

    2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.

    3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit.

    4. Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the study vaccination

    5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.

    Note: For participants who become hospitalized with coronavirus disease 2019 (COVID-19), participation in investigational treatment studies is permitted.

    1. Documented receipt of either 2 or 3 doses of the investigational Novavax vaccine with Matrix-M adjuvant (NVX- CoV2373); OR documented receipt of a full course of an FDA-authorized/approved COVID-19 vaccine; OR documented receipt of a full course of heterologous COVID-19 vaccines mentioned above. The most recent dose must have been administered at least 6 months prior to study vaccination.
    Exclusion Criteria:

    Participants meeting any of the following criteria will be excluded from the study.

    1. History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test)COVID-19 infection ≤ 4 months prior to randomization.

    2. Current participation in research involving receipt of an investigational product (drug/biologic/device).

    3. Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product.

    4. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression.

    5. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccine which may be received 4 days prior to study vaccine, or rabies vaccine which may be received at any time if medically indicated.

    6. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated.

    7. Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).

    8. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit.

    9. Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.

    10. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).

    11. Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).

    12. Participants with a history of myocarditis or pericarditis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Long Beach Clinical Trial Services Inc. Long Beach California United States 90806
    2 Long Beach Clinical Trial Services Inc Long Beach California United States 90806
    3 Benchmark Research Sacramento California United States 95864
    4 Accel Clinical Research DeLand Florida United States 32720
    5 Research Centers of America Hollywood Florida United States 33024
    6 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
    7 Multi-Specialty Research Associates, Inc. Lake City Florida United States 32055
    8 Atlanta Center for Medical Research ACMR Atlanta Georgia United States 30331
    9 Meridian Clinical Research Savannah Georgia United States 31406
    10 CRA Headlands Stockbridge Georgia United States 30281
    11 Velocity Clinical Research Boise Idaho United States 83642
    12 Meridian Clinical Research Sioux City Iowa United States 51106
    13 Meridian Clinical Research Baton Rouge Louisiana United States 70809
    14 MedPharmics Gulfport Mississippi United States 39503
    15 Sundance Clinical Research Saint Louis Missouri United States 63141
    16 Meridian Clinical Research Norfolk Nebraska United States 68701
    17 Meridian Clinical Research Omaha Nebraska United States 68134
    18 Meridian Clinical Research Endwell New York United States 13760
    19 Rochester Clinical Research Rochester New York United States 14609
    20 OnSite Clinical Solutions, LLC Charlotte North Carolina United States 28208
    21 CTI Clinical Research Center Cincinnati Ohio United States 45212
    22 Velocity Clinical Research Cleveland Ohio United States 44122
    23 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    24 Tekton Research Yukon Oklahoma United States 73099
    25 Velocity Clinical Research Grants Pass Oregon United States 97527
    26 Velocity Clinical Research East Greenwich Rhode Island United States 02818
    27 Benchmark Research Austin Texas United States 78705
    28 Tekton Research Austin Texas United States 78747
    29 Benchmark Research Fort Worth Texas United States 76135
    30 Research Your Health Plano Texas United States 75093
    31 Tekton Research San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Novavax

    Investigators

    • Study Director: Clinical Development, Novavax, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novavax
    ClinicalTrials.gov Identifier:
    NCT05463068
    Other Study ID Numbers:
    • 2019nCoV-307
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novavax
    Coronavirus
    COVID-19
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 20, 2022